Recall Z-1830-2025— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-1830-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-24

Class II · Ongoing

Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2025-04-24. It names one FDA 510(k) clearance: K171650. Product: ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.. Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result..

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class II
Status: Ongoing
Initiated: 2025-04-24
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K171650 — Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics·cleared 2017-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.

Reason for recall

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Data sourced from openFDA. This site is unofficial and independent of the FDA.